510(k) · Cleared
ClearedWet-Prep
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Jun 11, 1996 after a 32-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 11, 1996
- Review
- 32 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KLE device
- #1 K262252 MPa Max adhesivescore 15.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Bisco DENTIN CONDITIONER™ Named without a submission number | |
| * | — | Hema-Benz™ Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 2025
MAUDE reports naming product code KLE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 71 | 2 | 18 |
| 2008 | 3 | 66 | 0 | 9 |
| 2009 | 7 | 79 | 1 | 11 |
| 2010 | 8 | 93 | 1 | 13 |
| 2011 | 10 | 100 | 0 | 69 |
| 2012 | 5 | 66 | 0 | 176 |
| 2013 | 11 | 115 | 0 | 248 |
| 2014 | 6 | 120 | 0 | 260 |
| 2015 | 10 | 118 | 0 | 100 |
| 2016 | 3 | 148 | 1 | 47 |
| 2017 | 4 | 171 | 1 | 42 |
| 2018 | 8 | 124 | 0 | 31 |
| 2019 | 6 | 143 | 0 | 20 |
| 2020 | 6 | 195 | 0 | 6 |
| 2021 | 4 | 163 | 0 | 6 |
| 2022 | 8 | 98 | 0 | 7 |
| 2023 | 6 | 75 | 0 | 7 |
| 2024 | 7 | 61 | 1 | 12 |
| 2025 | 3 | 149 | 0 | 3 |
| 2026 | 7 | 84 | 0 | — |
What is it indicated for?
VET-PREP is used to re-wet dried dentin following acid etching and drying of the prepared cavity. Following etching the dentist typically air dries the etched enamel to check that a chalky-white appearance is present indicating that etching has occurred. At this point the dentin and enamel are too dry for effective penetration of subsequently applied primers. Hydrophilic primers will not effectively penetrate the dried collapsed collagen layer. If the…
Read the full statement (169 words)
VET-PREP is used to re-wet dried dentin following acid etching and drying of the prepared cavity. Following etching the dentist typically air dries the etched enamel to check that a chalky-white appearance is present indicating that etching has occurred. At this point the dentin and enamel are too dry for effective penetration of subsequently applied primers. Hydrophilic primers will not effectively penetrate the dried collapsed collagen layer. If the primer is unable to penetrate through collapsed collagen an effective seal will not occur and post-operative sensitivity is likely to result.
If WET-PREP is applied prior to application of the primers, it will effectively re-wet the collapsed collagen and allow for penetration of the hydrophilic primers through the moist collagen network. Enhancement of penetration of primers will improve the seal the restorative material makes with the prepared tooth. Since it is well known that microleakage is the predominant reason for post-operative sensitivity it is reasonable to assume an increase in sensitivity ought to result from the use of these products.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961822: Wet-Prep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961822
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026